BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No

    Recall: Z-0751-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0751-2025
    Event ID
    95760
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SEASPINE ORTHOPEDICS CORPORATION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2025
    Initiation Date
    October 29, 2024
    Classification Date
    December 23, 2024
    Address
    5770 Armada Dr, Carlsbad, CA, 92008-4608, United States

    Description

    Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No

    Reason

    Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

    Code Info

    Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E

    Distribution

    U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.

    Quantity

    92 devices